Regulatory Consulting Services for Clinical Trial Management
Clinical trials for pharmaceutical product development can be associated with many challenges. One key challenge that sponsors often face is navigating the complex & ever-evolving regulatory landscape and requirements imposed by global health authorities. They demand that clinical trial sponsors meticulously adhere to these requirements in order to ensure patient safety. Regulatory authorities encourage sponsors to maintain a balance between robust data collection and protecting trial participants well-being and this requires clinical trial protocols to be designed carefully and maintain adherence to ethical standards. Indeed, the landscape of clinical trial management is intricate due to the stringent regulatory requirements for data integrity, documentation, and transparency. This highlights the need for expert clinical trial regulatory services of CTA by regulatory consulting agencies, balance robust data collections & compliance.
Moreover, global harmonization of clinical trials poses challenges for sponsors as different countries typically have diverse regulatory requirements. For multinational trials, harmonizing protocols, endpoints, and data reporting becomes critical. Therefore, it is imperative to have a communication channel with regulatory authorities to address queries, modifications, and clinical trial approvals in a timely manner. This would significantly contribute to minimizing delays along the product development timeline. As clinical regulations continue to change, the need for in-depth regulatory consulting for clinical trial management and expertise that evolves with the changing landscape, from region to region, is more than ever.
Clinical Trial Application Submissions
One of the pain-points that clinical trial sponsors often face are clinical trial application submissions to healthcare authorities. These are required by the authority of the country in which the sponsor wishes to conduct their clinical trial. In order to obtain clinical trial approval, a clinical trial application (with the required documentation) must be submitted in accordance with the authority’s regulations. These regulations may differ from country to country presenting sponsors with challenges as they navigate through the intricate clinical trial landscape.
For example, the clinical trial approval process in the USA requires sponsors to file an Investigational New Drug (IND) application with the US FDA. However, the approval process in the European Union (EU), including the United Kingdom (UK), requires sponsors to submit an Investigational Medical Product Dossier (IMPD). Typically, once the clinical trial application has been submitted, the healthcare authority shall review and request additional information if needed. The data requirements for clinical trial applications differ depending on the phase of the clinical trial in question. If the information & documentation is sufficient, the healthcare authority provides the clinical trial sponsor with formal approval proceed with conducting the clinical trial. However, if the information is not sufficient then this could delay the entire clinical trial regulatory approval process which could be burdensome for trial sponsors.
Overall, obtaining clinical trial approval can be challenging particularly for sponsors looking to conduct a trial in a new country. In addition to ensure all data requirements are met, there can be other many other challenges including preparation of the trial application (i.e, clinical study report writing), translation of documents, in-country support for submission & liaison, etc. For trials being conducted in multiple countries, it becomes imperative to integrate the procedures involved for clinical trial applications and approvals. It is important to partner with experts that have the infrastructure and knowledge of clinical trial application filing processes for multiple countries. Regulatory agencies are becoming more stringent with their documentation requirements before granting clinical trial authorization. Examples of such documents include diversity plans, pediatric investigation plans, clinical trial subject rights (i.e., insurance, informed consent) and so on. It is necessary to ensure these documents are developed per the required structure & format of the agency and include.
DDReg’s Expertise in Regulatory Consulting for Clinical Trial Management
DDReg’s expertise in regulatory consulting for clinical trial management supports all aspects of obtaining clinical trial approval. With the right blend of knowledge, skillset, and local presence allowing efficient communication channels with competent authorities & ethics committees for clinical trials, DDReg is your go-to partner for customized and tailored clinical trial approval support. The team is equipped in providing the required support for clinical study report writing, clinical trial application due diligence, physical and e-submission of clinical trial applications, and clinical trial regulatory solutions support for US, UK, and RoW submissions.
DDReg’s Expertise in Clinical Regulatory Affairs Services Includes:
Developing robust and comprehensive clinical regulatory strategies for clinical trial application submission for the USA, EU, ASEAN, MENA, LATAM regions
Support in clinical study report writing per country regulations.
Providing strategic advice for clinical trial applications for target markets to minimize the agency queries.
Conducting meticulous regulatory clinical trial application due diligence and for early phase clinical protocols
Regulatory Gap analysis and remediation plans for identified concerns.
Support for pre–IND meetings with the US FDA (Type A, B, C, etc)
Development & review of clinical documentation (i.e., development of investigator’s brochure, information consent form)
Authoring, compiling, reviewing, and submitting clinical trial application packages.
e-submission of clinical trial applications
Responding the clinical queries from regulatory agencies regarding clinical trial application submissions
Translation services for clinical trial documentation
Post-submission clinical activities (i.e., amendments, trial notifications)
Support for the US FDA Diversity Plan includes collating available information for planned studies and Racial and Ethnic Minority (REM) subgroups.